In the third installment of this podcast series, Dr. Mira Francis presents Algorithme Pharma's experience in effectively planning and recruiting for Diabetes Clinical Trials and important factors to consider for early stage study designs.

This session focuses on methods to overcome limitations of Dried Blood Spot analysis and highlights the Pre-Cut technique for use in analyzing New Molecular Entities and Biomarkers. It includes the recent IQ recommendations on refining DBS to meet regulatory requirements. Participants were provided with an overview of key points to consider for DBS analysis and what is required for regulatory agency acceptance. This session includes key scientific insights on the following DBS issues: hematocrit impact, dilution effect, internal standard techniques & stability considerations. Hosted by Dr. Fabio Garofolo at the March 2014 SOT Meeting.

This presentation examines study design considerations used in developing efficient FIH clinical trials. With the recent trends evolving in drug development models, FIH study design considerations typically now include sponsor objectives, regulations, type of compounds and timelines. However, external factors such as formulations, bioanalytical methods, study population and safety events can have a significant study design impact. In this session, we use a case study analysis to discuss the development of efficient study designs while accounting for standard considerations and external factors. Presented at The Science Exchange Symposium, February 27th, 2014 in Montreal, Quebec, Canada.

Curious to see inside our newest clinic expansion? Step right in and take the Street View Tour!

The modern design enhances the participant experience with 3 independent lounges, soundproof dormitories and facility-wide complimentary WiFi. The open concept processing and nursing areas enables sponsors to benefit from increased flexibility and efficiency in safely conducting complex study designs requiring large panel sizes.

A great addition to our existing facility, the clinic has been designed in response to our sponsors’ early phase development needs, as well as for the safety, functionality and comfort of our study participants.

The determination of transferrin-bound iron (TBI) in human serum is a requirement of the FDA Draft Guidance on Ferumoxytol. A highly selective and robust assay was developed, validated and used in clinical bioequivalence (BE) studies.

How to deliver full panels on-time. Presented by Ingrid Holmes and Petra Hillebrand, this webinar highlights a solutions-based approach to filling large panels for complex trials, while incorporating special populations in a high volume environment. Specifically using three case studies focusing on special populations (Hypogonadal males, Type I/II Diabetes and Post-Menopausal women), they demonstrate how optimal recruitment strategies can be effectively used to meet increasingly complex participant requirements in early stage clinical development.

Fabio Garofolo, VP of Bioanalytical Services, Algorithme Pharma spoke at the 20th International Reid Bioanalytical Forum about the matrix effects special focus issue that he recently guest edited for Bioanalysis.

Our goal is to provide the best quality early stage clinical development services to an international customer base of biotechnology and pharmaceutical companies with a focus on customer service. We will achieve this by continuously looking for ways to improve our customer relationships and range of services and by creating an environment that provides value for our customers, respect for our participants and growth for our employees.

The primary success of a clinical trial depends on recruitment and enrollment of the appropriate study population in an adequate screening window. In early stage trials, we base the success of these steps on Inclusion and Exclusion (I/E) criteria. However, as study designs are becoming more complex, how could these designs impact recruitment and enrollment power? The following poster podcast is a case study illustrating the same study population with similar Inclusion and Exclusion criteria, and demonstrates the impact of a complex design on recruitment and enrollment.

Josée Michon, Associate Director Method Development, explains the bioanalytical challenges during clinical sample collections as illustrated by three case studies, as well as recommendations. Presented at the October 2013 Science Exchange Symposium.